TwitchView™

GUDID 00860298001086

Supporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With the flexibility to secure to either left or right hand in seconds, the Electrode Array is easily adopted into the pre-surgical workflow. The one-piece, auto-centering design mitigates placement errors—a common cause of intra-operative system failure and measurement inaccuracies.

BLINK DEVICE COMPANY

Neuromuscular transmission electrode

• Primary Device ID: 00860298001086
• NIH Device Record Key: 18634b3f-962b-4495-a511-f5735dd1e606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TwitchView™
• Version Model Number: Electrode v1
• Company DUNS: 105714027
• Company Name: BLINK DEVICE COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860298001055 [Primary]
GS1	00860298001086 [Package]; Contains: 00860298001055; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172843

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-08
• Device Publish Date: 2018-09-05

On-Brand Devices [TwitchView™]

• 00860298001079: A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode
• 00860298001086: Supporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With
• 00860298001048: A pole-mounted wireless charging dock for the TwitchView™ Monitor that simplifies the clinical
• 00860298001031: TwitchView™ utilizes advanced electromyography (EMG) to quantify a patient's depth of neuromus
• 00860298001093: A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode
• 00850023319029: A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode